This study aims to see if patient quality of life can be approved after treatment with an injectable medication called ustekinumab for the treatment of generalized psoriasis. The investigators hypothesize that the investigators will see improvement in quality of life.
The primary objective of this study is to demonstrate improvement in psoriasis patient quality of life after 36 weeks with ustekinumab through the use of validated dermatologic and non-dermatologic psychometric instruments.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Biologic agent: sub-cutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter.
UCSF Psoriasis and Skin Treatment Center
San Francisco, California, United States
Improvement in Quality of Life Measured by Change in Psychological General Well-Being Scale (PGWB) at Week 36 From Baseline.
The PGWB is a self-administered validated psychometric instrument that measures a person's emotional well-being. It is specifically designed to be suitable for assessing psychological well being in the general medical population as opposed to a psychiatric population. The 22 questions of the PGWB can be further divided into 6 domains: anxiety, depressed mood, positive well being, self-control, general health, and vitality. The PGWB is graded on a Likert scale, which is commonly used in psychometric questionnaires where the answers range from strongly agree to strongly disagree with gradations in between. Total scores range from 0 to 110, with higher scores indicating better psychological well being. This instrument has been validated and used in many countries on large samples of the general population and on various subsets of medical patients.
Time frame: Baseline, 36 weeks
Change in Psychological General Well-Being Scale (PGWB) Over Time (at Weeks 12 and 24) From Baseline
The PGWB is a self-administered validated psychometric instrument that measures a person's emotional well-being. It is specifically designed to be suitable for assessing psychological well being in the general medical population as opposed to a psychiatric population. The 22 questions of the PGWB can be further divided into 6 domains: anxiety, depressed mood, positive well being, self-control, general health, and vitality. The PGWB is graded on a Likert scale, which is commonly used in psychometric questionnaires where the answers range from strongly agree to strongly disagree with gradations in between. Total scores range from 0 to 110, with higher scores indicating better psychological well being. This instrument has been validated and used in many countries on large samples of the general population and on various subsets of medical patients.
Time frame: Baseline, 12 and 24 weeks
Change in Work Productivity and Activity Impairment Scale (WPAI-PSO) Over Time at Week 36 From Baseline
The WPAI is a patient-reported quantitative assessment of the amount of absenteeism, presenteeism and daily activity impairment attributable to general health or a specific health problem. The WPAI:PSO was created specifically for administering to patients with psoriasis. WPAI surveys were analyzed based on published algorithms to determine the following: current employment status, absenteeism (percentage of time missed from work due to psoriasis), presenteeism (percentage reduced productivity at work due to psoriasis), total activity impairment (TAI, percentage impairment in activities other than work due to psoriasis), and total work productivity impairment (TWPI, total percentage of work impairment from both absenteeism and presenteeism due to psoriasis). Each WPAI score is expressed as impairment percentages (0-100), with higher scores representing greater impairment (worse outcomes)
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Time frame: Baseline, 36 Weeks
Change in Psoriasis Quality of Life - 12 Items (PQOL-12) Over Time (at Weeks 12, 24, and 36) From Baseline
The PQOL-12 is a 12-item psoriasis-specific validated PRO based entirely on the patient's own assessment of their situation. The items were data-derived based on a series of population-based statistical studies and clinical trials conducted over a decade. The KMPI is one of the first tools used in dermatology to incorporate a validated PRO in critical medical decision-making. The scores range from 0-120 with higher scores indicating worse outcomes.
Time frame: Baseline, 12, 24, and 36 Weeks
Change in Dermatology Life Quality Index (DLQI) Over Time (at Weeks 12, 24, and 36) From Baseline
The DLQI is a 10-item self-reported survey, which addresses feelings, daily activities, leisure, work, school, personal relationships, and treatment. Each question item is worth 3 points (total maximum score of 30), with higher score representing greater QoL impairment.
Time frame: Baseline, 12, 24, and 36 Weeks
Percentage of Patients Achieving PGA of Clear or Almost Clear at Weeks 12, 24, and 36
The Physician Global Assessment (PGA) scoring system is used to assess the severity and extent of psoriasis using a score of 0-6 (clear, almost clear, minimal, moderate, severe, to very severe) averaged over all lesions.
Time frame: Weeks 12, 24, and 36
Percentage of Patients Achieving PASI-75 at Weeks 12, 24, and 36
The Psoriasis Area and Severity Index (PASI) incorporates erythema, induration, and scale on a score of 0-4 weighted by percentage of body surface area involvement. PASI scores range from 0 to 72, with higher scores indicating worse disease. The percentage of patients achieving 75% reduction or better from the baseline PASI score in a designated time period has become the gold standard to measure the efficacy of psoriasis treatment options.
Time frame: Weeks 12, 24, and 36